SILVIO O. CONTE CENTERS FOR THE NEUROSCIENCE OF MENTAL DISORDERS
RELEASE DATE: July 1, 2002
PA NUMBER: PAR-02-122 (Reissued as PAR-07-433)
(See Notice NOT-MH-06-120)
(See Notice NOT-MH-06-118)
Extending the expiration dates and change the cost limitations and application receipt dates
EXPIRATION DATE: October 26, 2006, unless reissued
National Institute of Mental Health (NIMH)
(http://www.nimh.nih.gov/)
LETTER OF INTENT RECEIPT DATE: August 1 2002, July 1 annually thereafter
APPLICATION RECEIPT DATE: October 21, 2002, October 20 annually
This program announcement (PA) replaces PAR-98-058, which was published in the
April 17, 1998 issue of the NIH Guide.
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this PA
o Research Objectives
o Mechanism of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
The National Institute of Mental Health (NIMH) invites research center grant
applications for Silvio O. Conte Centers for the Neuroscience of Mental
Disorders (CCNMD): Schizophrenia, Mood Disorders, and Other Severe Mental
Illnesses. The primary goal of this initiative is to support integration and
translation of basic and clinical neuroscience research on severe mental
illnesses. Research supported by these centers should seek to clarify the
neural substrates of mental disorders, including the etiology and pathogenesis
of those disorders and the biological phenotypes associated with them. Such
knowledge will ultimately enhance capabilities to diagnose, monitor, treat, and
prevent mental disorders. This program announcement represents a major NIMH
commitment to these goals.
These Centers will comprise integrated teams pursuing highly focused research
that is driven by a single hypothesis related to environmental, genetic and/or
other biological factors in brain development, structure and/or function as they
relate to mental illness. Centers must use innovative research designs and
state-of-the-art technologies with a high level of integration among and across
projects. Centers should draw upon eminent basic and clinical scientists to
form unique collaborations optimally suited to address the research questions
posed. Therefore, Centers may have heads of projects from several different
institutions.
In addition to the Silvio O. Conte Centers for the Neuroscience of Mental
Disorders, NIMH has a number of other center mechanisms with somewhat different
programmatic goals. The purposes of these other mechanisms, and links to the
relevant announcements, are summarized below:
o Applicants who have all the elements expected of a Conte Center for the
Neuroscience of Mental Disorders or a Conte Center for Neuroscience Research
(see below) except for established collaborative research across participating
laboratories, should consult (PAR-02-123)
(http://grants.nih.gov/grants/guide/pa-files/PAR-02-123.html), Silvio O. Conte
Centers to Develop Collaborative Neuroscience Research,
o Applicants interested in funding for a Center for basic neuroscience research
relevant to mental disorders should consider (PAR-02-121), Silvio O. Conte
Centers for Neuroscience Research
(http://grants.nih.gov/grants/guide/pa-files/PAR-02-121.html),
o Applicants interested in funding for a Center for research at the interface
between basic behavioral research and neuroscience should see PAR-00-130,
Interdisciplinary Behavioral Science Centers for Mental Health
(http://grants.nih.gov/grants/guide/pa-files/PAR-00-130.html),
o Applicants interested in funding for a Center that would foster research
projects on the translation of basic behavioral research to mental disorders and
public health applications should consider PAR-01-027, Translational Research
Centers in Behavioral Science
(http://grants.nih.gov/grants/guide/pa-files/PAR-01-027.html),
o Applicants seeking to establish core infrastructure support for mental health
services and interventions research are referred to PAR-01-089, Advanced Centers
for Interventions and Services Research
(http://grants.nih.gov/grants/guide/pa-files/PAR-01-089.html) and PAR-01-090,
Developing Centers for Interventions and
Services Research (http://grants.nih.gov/grants/guide/pa-files/PAR-01-090.html),
and
o Those interested in a Center with a focus on HIV/AIDS should apply for
funding through PAR-99-153, Core Support Program for Mental Health/AIDS Research
(http://grants.nih.gov/grants/guide/pa-files/PAR-99-153.html).
RESEARCH OBJECTIVES
Background
The major mental disorders affect approximately 15-20 percent of the U.S.
population annually. These disorders include schizophrenia, mood disorders,
anxiety disorders, childhood and adolescent mental disorders, sleep disorders,
eating disorders, and dementias. The staggering cost of treating these
disorders is surpassed only by the immeasurable cost in human suffering endured
by these patients and their families through extended and recurring periods of
illness and distress.
Basic neuroscience research has provided new insights into schizophrenia and
other severe mental illnesses, thus offering a new understanding of the symptoms,
pathophysiology, and etiology of these disorders. At the same time, clinical
research has generated hypotheses implicating genetic, viral, developmental,
neurochemical, connectional and other biological factors in mental disorders.
The time is propitious for bringing together basic and clinical approaches to
better understand and address mental illness, support of these specialized
Centers (CCNMDs) represents a significant NIMH commitment to the promotion of
such integration.
Objectives and Scope
The primary purpose of each CCNMD is to support a multidisciplinary team of
leading basic and clinical neuroscience researchers engaged in a highly
integrated, focused, and hypothesis driven research program. A CCNMD is
characterized as follows:
o Since the integration of basic and clinical research is the primary goal,
each CCNMD must demonstrate the ability to translate and integrate data between
basic and clinical studies. Accordingly, each individual project in the CCNMD
should be designed to inform, and be informed by, findings from many of the
other projects within the Center, for example, testing basic research findings
in appropriate and adequate clinical populations, as well as testing hypotheses
generated from clinical research in a basic science setting.
o The total scientific enterprise must be organized around a multidisciplinary
effort directed at a single hypothesis in order to understand a specific aspect
of mental illness. Integration of basic and clinical research to address a
highly focused hypothesis is paramount.
o It is expected that a Center will be organized specifically to address
innovative, creative, and potentially high risk/high impact research questions.
Centers must rigorously test the proposed hypothesis and generate new ones. It
is expected that such research will advance neuroscience in fundamental and
significant ways.
o A CCNMD should clearly demonstrate a high level of interdependence of
projects and investigators, and solid evidence of integration between the basic
science and clinical components.
o The Center mechanism may not be used as a substitute for individual grant
support. It is, therefore, expected that investigators participating in Centers
will have independent, peer reviewed research support. A Center must be viewed
as a unique scientific opportunity to investigate leading edge research
questions not currently being addressed in optimal ways.
o The CCNMD Director should have a demonstrated capability to organize,
administer and direct the Center. This individual should be the scientific
leader of the Center, and thus must also head at least one of the projects, with
a minimum total time commitment of 30 percent to the Center.
o Investigators heading projects in a CCNMD should be prominent scientists in
basic and/or clinical neuroscience research who are at once leaders of their
respective fields and actively involved in research. Investigators with the
qualifications to contribute to a unique enterprise such as a CCNMD may be
located in different geographic areas. Therefore, collaborations among
different institutions are encouraged, if scientifically appropriate.
o A CCNMD should provide opportunities for young investigators who have the
potential for independent research careers to develop integrative research
programs combining basic and clinical neuroscience research. In addition, there
should be close coordination between the Center and relevant predoctoral and/or
postdoctoral research training programs of the participating institution(s).
Special attention should also be given to the recruitment and training of
minority students.
o Each CCNMD should provide outreach that makes the public aware of the
importance and implications of the CCNMD research for addressing basic
neuroscience issues and those that relate to clinical aspects of mental illness
and mental health.
Research Topics
The primary goal of this initiative is to support integration and translation of
basic and clinical neuroscience research on schizophrenia and other severe
mental illnesses. Research supported by these Centers should seek to better
understand the neural substrates of mental disorders, including the etiology and
pathogenesis of those disorders and the biological phenotypes associated with
them. The following are examples of broad research areas within the NIMH
research mission that might serve as a focus for a CCNMD. This list is not
meant to be comprehensive, nor are the examples meant to be exclusive of other
topics.
o Studies that use quantitative, molecular biological and/or genetic approaches
to investigate the development of neuronal populations related to specific
cognitive and/or behavioral functions, such as the developmental etiology of
schizophrenia hypothesis, or to investigate the genetic heterogeneity of and
susceptibility to mental illness in patient populations
o Studies of the relationship between emotion and cognition in animals and
humans, including human subject populations with and without mental disorders,
animal studies could include the use of animal models of psychopathology
o Identification of circuits underlying specific behaviors in animals and
humans, and testing hypotheses linking such circuit level understanding with
studies of normal and abnormal brain function using functional imaging
approaches
Silvio O. Conte Centers for the Neuroscience of Mental Disorders are intended to
support research in basic and clinical neuroscience relevant to the mission of
NIMH. Since appropriate research covers a wide swath of neuroscience,
prospective applicants are also referred to the website that describes research
programs of the Division of Neuroscience and Basic Behavioral Science, which
funds Conte Centers for the Neuroscience of Mental Disorders. The URL is
http://www.nimh.nih.gov/diva/index.htm. Please note that although program staff
are listed on the website, program inquires about CCNMDs should be directed to
the program staff listed under INQUIRIES.
MECHANISM OF SUPPORT
This PA will use the National Institutes of Health (NIH) center award mechanism
(P50), which provides funding for multidisciplinary and multi-investigator
approaches to the investigation of specific and complex research problems
requiring the application of diverse expertise and methodologies. As an
applicant, you will be solely responsible for planning, directing, and executing
the proposed Center.
Applicants may request support for a period of up to five years, followed by a
competitive renewal application for a second five year period. The NIMH will
not support individual Centers for longer than two consecutive funding periods.
Direct costs are limited to $1.5 million in any one year, this limit applies to
new grants, their non-competitive continuations, and any subsequent competitive
renewals. Since the best scientific talent and resources are expected to be
brought to bear on questions posed in each Center, and since these are often not
all available at any single institution, projects constituting a given Center
may be based at multiple institutions. In an effort to allow for such multi-
institutional involvement, for the purposes of this program announcement,
Facility and Administrative (F&A) costs for consortium activity at collaborating
institutions will not be counted against the $1.5 million limit to direct costs
(but these costs should be delineated as instructed in form PHS 398 [rev.
5/2001]).
Competitive supplements will not be considered for these Center grants. It is
anticipated that individual projects, which are developed as outgrowths of a
Center grant, will seek independent funding through mechanisms such as the
research project grant (R01) mechanism.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the following
characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic
Foreign institutions are not eligible for Center grants.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry out
the proposed research is invited to work with their institution to develop an
application for support. Racial/ethnic minority individuals, women, and persons
with disabilities are encouraged to apply as CCNMD Directors and heads of
projects or cores.
SPECIAL REQUIREMENTS
Sharing Data, Biological Material Resources, and Tools
Public Health Service (PHS) policy requires that investigators make unique
research resources readily available to qualified individuals within the
scientific community for research purposes following publication (the current
NIH Grants Policy statement is dated March 1, 2001 and may be found at
http://grants.nih.gov/grants/policy/nihgps_2001/). The intent of this policy,
however, is not to discourage, impede, or prohibit the organization that
develops unique research resources or intellectual property from commercializing
the products.
CCNMDs marshal the very best researchers and resources for investigating
neuroscience and mental disorders, and novel data, materials and tools, which
can be difficult to develop under smaller mechanisms, are often the result.
Therefore, the NIMH requires applicants to develop detailed plans for the
dissemination of data and materials generated through the Center through
commercial or non-commercial means. (It should be noted that even with
non-commercial paradigms, the cost of developing such resources for distribution
and the cost of distributing them may be charged to those requesting them.)
The plan should be described in the Operational Plan for the CCNMD, and the
adequacy of the plan will be considered by NIMH staff in determining whether the
grant should be awarded. The initial review group will comment on the proposed
plan for sharing and the adequacy of the plan is among the review criteria. The
sharing plan as approved, after negotiation with the applicant when necessary,
will be a condition of the award.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into three areas:
scientific/research, peer review, and financial or grants management issues:
o Direct your questions about scientific/research issues and address the letter
of intent to:
Steven J. Zalcman, M.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7177, MSC 9639
Bethesda, MD 20892-9639
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-1692
FAX: (301) 402-4740
Email: szalcman@mail.nih.gov
o Direct your questions about peer review issues to:
Michael Kozak, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC 9608
Bethesda, MD 20892-9608
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-1340
FAX: (301) 443-4720
Email: mkozak@nih.gov
o Direct your questions about financial or grants management matters to:
Ms. Carol J. Robinson
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6118, MSC 9605
Bethesda, MD 20892-9605
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-3858
FAX: (301) 443-6885
Email: crobinso@mail.nih.gov
LETTER OF INTENT
Prospective applicants are strongly encouraged to contact the program staff
member listed under INQUIRIES as early as possible in the conceptualization of a
possible application for a CCNMD.
Prospective applicants are asked to submit a letter of intent that includes the
following information:
o Descriptive title of the proposed research
o Name, address, telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this PA
Although a letter of intent is not required, is not binding, and does not enter
into the review of a subsequent application, the information that it contains
allows NIMH staff to estimate the potential review workload and to plan the
review.
The letter of intent is to be sent by the date listed at the beginning of this
document. The letter of intent should be sent to:
Steven J. Zalcman, M.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7177, MSC 9639
Bethesda, MD 20892-9639
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-1692
FAX: (301) 402-4740
Email: szalcman@mail.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format.
For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email:
GrantsInfo@nih.gov.
Application Format Guidelines
A major requirement for each Center is the conduct of multidisciplinary research
integrating and translating basic and clinical approaches. The application must
describe the hypothesis to be tested, the goals of, and the approaches used in
the Center.
In addition, the application should clearly articulate the reasons a Center
approach is needed for the proposed work as well as the unique benefits that
will accrue from having a Center in this research area rather than addressing
the research issues through other modes of support. It should be emphasized
that this center mechanism is not meant to be a substitute for individual grant
support. Therefore, the reasons that constituent projects require Center
support should be fully justified.
The application should utilize PHS Form 398 and include the following components
in the specified order:
Information for the Entire Center:
o Face Page (noting this program announcement in Item 2) - Information provided
here should pertain to the entire Center.
o Description, Performance Sites, and Key Personnel (Form Page 2) - Information
provided here should pertain to the entire Center.
o Table of Contents (Form Page 3)
o Budget Information (Form Pages 4 and 5) - Categorical figures should be
provided to reflect the budget of the overall Center. Since detailed budget
justification will be provided separately for each project and core (as
described below), only items for which justification is not provided elsewhere
should be presented in narrative here.
o Biographical Sketches of Key Personnel - Biographical sketches should be
provided for key personnel of the entire Center, and should be arranged
alphabetically based on the individual"s surname.
o Resources - Resources described here should be restricted to those not
described separately for the individual projects and cores (as described below).
o General Description of the Overall Center (Not to exceed 10 pages, for
revised and resubmitted applications, a one-page introduction is allowed to
describe changes from the previously submitted version):
Provide an overview of the entire proposed Center describing the central
hypothesis to be tested and goals to be achieved. Describe how the overall
Center will achieve its major objectives. Explain the proposed contribution of
each of the projects and cores in achieving the objectives of the Center and how
these components, especially the projects, relate to each other scientifically.
o Evidence of Feasibility and Preliminary Findings (for new, Type 1,
applications and amended Type 1 applications only, not to exceed 10 pages, for
revised and resubmitted applications, a one-page introduction is allowed to
describe changes from the previously submitted version)
Present evidence that the research team will be able to work together to
accomplish the research proposed in the projects, present preliminary results,
present evidence of competence in the areas proposed, etc.
If previously supported by an NIMH Silvio O. Conte Feasibility Center for
Neuroscience Research, indicate the outcome of that specific activity as it
relates to the application for the proposed Center support.
o Progress Report (for competing renewal, Type 2, applications and amended Type
2 applications only, not to exceed 3 pages for each project supported in the
antecedent Center grant, for revised and resubmitted applications, a one-page
introduction for the entire Progress Report is allowed to describe changes from
the previously submitted version)
Describe the results of each of the projects supported in the previous CCNMD
grant and the manner in which those results and projects relate to the currently
proposed Center application. Describe the manner in which the Center mechanism
provided synergy to the previously funded Center.
o Operational Plan for Overall Center (not to exceed 11 pages, for revised and
resubmitted applications, an extra one-page introduction is allowed to describe
changes from the previously submitted version)
The working administrative and logistical arrangements, as well as the resource
support necessary to implement the research, should be fully elaborated in the
application. Particular attention should be devoted to a description of the
clinical populations, tissue resources, etc., which will be involved as part of
the Center"s clinical component. When multiple institutional sites are involved,
a detailed description of the cooperative administrative arrangements should be
included (documentation of these arrangements should be included in the "Letters
of Support" section).
Also included in this section is the manner in which an external advisory board
will advise the Center. Prospective board members should not be chosen or
contacted prior to a funding decision and therefore should not be named.
The plan for sharing data, biological material resources, and tools generated by
the Center should also be included in this section.
o Research Career Development and Outreach Plans (not to exceed 2 pages)
A description of the manner in which Center activities will provide
opportunities for young investigators and how the proposed CCNMD relates to
existing training programs of participating institutions should be given. Also,
plans for disseminating information to the public regarding the activities of
the Center should be given.
Information for Each Project or Core:
For each project or core, the information should be arranged in the following
order:
o Cover Page - Information provided here should pertain specifically to the
project or core.
o Description, Performance Sites, and Key Personnel (Form Page 2) - Information
provided here should pertain specifically to the project or core.
o Budget Information (Form Pages 4 and 5) - Detailed budget information should
be
provided for each project or core, with a narrative justification given for all
budget items.
o Resources - Resources should be described for each project or core.
o Research Plan for Individual Projects (Not to exceed 10 pages for any one
project, for revised and resubmitted applications, an additional one-page
introduction for each project is allowed to describe changes from the previously
submitted version.)
The research plan for each project should describe the specific aims, background
and significance. In these sections, the research question to be addressed and
the hypothesis to be tested by the proposed research project should be highly
focused and fully explained. Full discussion is required on: the status of
current research efforts addressing the issue (both within the Center and
elsewhere), the limitations of existing research strategies, why the particular
research question lends itself to a multidisciplinary, integrative approach, and
how the proposed project is to be linked and integrated with other proposed
Center projects. In addition, the relationship between the basic and clinical
science aspects of the research should be made explicit.
The research plan for each project should also include a description of the
research design and methods. This will not require extensive details for
individual experiments. Description of the experimental design should outline
the strategies proposed to accomplish the specific aims of the project and
should include a discussion of the innovative aspects of the approach.
Experimental procedures need not be spelled out in great detail if those
procedures have already been extensively published and widely accepted by the
scientific community, the methods to be used should be cited and referenced.
Any new methodology, however, and its advantage over existing methodologies,
should be fully described. Further,
the feasibility of the proposed experiments, potential pitfalls, alternative
approaches, if necessary, and relevance to Center goals should be discussed, as
should plans for data sharing.
o Descriptions of Individual Cores (Not to exceed 8 pages for any one core, for
revised and resubmitted applications, an extra one-page introduction is allowed
to describe changes from the previously submitted version.)
Describe how the core will contribute to the overall goals of the Center as well
as which projects will be supported by the core and the manner in which that
support will be rendered by the core. The description of each core should
clearly indicate the facilities, resources, services, and professional skills
that the facility will provide to the proposed Center.
o Human Subjects - For each individual project and core involving human
subjects, describe the plans for protection of subjects from research risks, as
well as plans for the inclusion of women, minorities, and children, as described
in the PHS 398 application instructions (rev. 5/2001).
o Vertebrate Animals - For each individual project and core involving
vertebrate animals, provide a detailed description and justification for the use
of animals as described in the PHS 398 application instructions (rev. 5/2001).
Other Information:
o Literature Cited - This section should include and compile literature cited
throughout the application.
o Letters of Support from Institutions and Collaborators - Also included in
this section should be assurances from Institutional Animal Care and Use
Committees and/or Institutional Review Boards (though the latter is not required
for peer review).
o Checklist
o Personal Data on Center Director
SENDING AN APPLICATION TO THE NIH: The title and number of this program
announcement must be typed on line 2 of the face page of the application form
and the YES box must be marked.
Submit a signed, typewritten original of the application, including the
Checklist, and three signed photocopies in one package to:
CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application must be sent
to:
Jean Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892-9609
Rockville, MD 20852 (for express/courier service]
Telephone: (301) 443-3367
FAX: (303) 443-4720
Email: jnoronha@mail.nih.gov
APPLICATION PROCESSING: Applications must be received by the application
receipt date listed in the heading of this PA. If an application is received
after that date, it will be returned to the applicant without review.
The Center for Scientific Review (CSR) will not accept any application in
response to this PA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application. The CSR
will not accept any application that is essentially the same as one already
reviewed. This does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include an
Introduction addressing the previous critique.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed by CSR for completeness and by NIMH
program staff to determine if they satisfy the objectives and requirements of a
CCNMD as outlined in this program announcement (excluding scientific or
technical merit). Applications that do not meet these objectives and
requirements will not be accepted and will be returned to the applicant.
Applications that are complete and responsive will be evaluated for scientific
and technical merit by an appropriate scientific review group convened by the
NIMH in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
o Receive a written critique and priority score
o Receive a second level review by the National Advisory Mental Health Council.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In the
written comments, reviewers will be asked to discuss the following aspects of
your application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals. The scientific
review group will address and consider each of these criteria in assigning your
application"s overall score, weighting them as appropriate for each application.
Criteria for scientific/technical review of CCNMD applications will include the
following:
o Intrinsic merit of the intellectual focus and research: the overall quality,
scientific merit, and innovation of the research to be done, the likelihood that
the work will lead to fundamental advances within the field, to new discoveries,
and/or to new technological developments, in addition, the research conducted
must center around a highly focused and well-defined question.
o Integration of and translation across basic science and clinical research
components: the adequacy of the proposed Center to bring together basic and
clinical approaches so that activities in each component inform and advance the
others.
o Appropriateness of the Center approach: the need for and suitability of the
Center approach, whether a Center approach will add significantly to what could
be done through other modes of research support, in this respect, the
integration and synergy of the projects are of utmost importance and should be
explicitly described.
o Research competence: the capability and scientific credentials of the Center
Director and constituent project directors and participating scientists, who are
expected to be regarded by their peers as leaders in, and at the forefront of,
their respective fields.
o Center Director credentials: ability of the Center Director to organize,
administer, and direct the Center and, in addition, head at least one of the
proposed projects, be it basic or clinical in nature, a Center Director will
devote a minimum of 30 percent of his/her time to the Center. The Director
must, by necessity, be the scientific leader of the Center.
o Institutional commitment: the nature and level of resource commitments from
the home institution and from other participant institutions, and plans for
interactions with the rest of the participating institutions.
o Appropriateness of management plans and arrangements: the feasibility and
adequacy of the organizational and administrative plans, the appropriateness of
the budget, and the mechanisms to evaluate the Center"s progress.
o Appropriateness of the proposed plan to share data, biological material
resources, and tools (the plan may use commercial and/or non-commercial
approaches).
o Quality and appropriateness of the outreach and research career development
components of the Center"s activities: the adequacy of approaches used to
disseminate information regarding the Center"s activities as they relate to
public understanding of science and mental health and illness, the likely
effectiveness of approaches to attract and involve young investigators and
students who show potential for significant future contributions and independent
research careers in the work of the Center.
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application
will also be reviewed with respect to the following:
o PROTECTIONS: the adequacy of the proposed protection for humans, animals, or
the environment, to the extent they may be adversely affected by the project
proposed in the application.
o INCLUSION: the adequacy of plans to include subjects from both genders, all
racial and ethnic groups (and subgroups), and children as appropriate for the
scientific goals of the research, plans for the recruitment and retention of
subjects will also be evaluated.
o BUDGET: the reasonableness of the proposed budget and the requested period
of support in relation to the proposed research
The initial review group will make an overall recommendation for approval (and
assign a priority score) or disapproval of the entire Center application. Under
some circumstances, it may be appropriate for the initial review group to
recommend disapproval of one or more project(s).
RECEIPT AND REVIEW SCHEDULE
To ensure a uniform review quality, all applications will be reviewed by a
single review group, which will meet once per year. In accordance with this
objective, there will be one receipt date each year. Applications received
after this date will be returned to the applicant without review.
Letter of Intent Receipt Date: August 1 2002, July 1 annually thereafter
Application Receipt Date: October 21, 2002, October 20 annually thereafter
Administrative Review: November
Scientific Review: April/May
Advisory Council Review: May/June
Earliest Starting Date: July
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o scientific merit (as determined by peer review)
o availability of funds
o programmatic priorities
REQUIRED FEDERAL CITATIONS
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS: It is
the policy of the NIH that women and members of minority groups and their sub-
populations must be included in all NIH-supported biomedical and behavioral
research projects involving human subjects, unless a clear and compelling
rationale and justification are provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research. This policy results from the NIH Revitalization Act of 1993 (Section
492B of Public Law 103-43).
All investigators proposing research involving human subjects should read the
AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research - Amended, October, 2001," published in the NIH Guide for
Grants and Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete
copy of the updated Guidelines is available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research, updated racial and ethnic categories in compliance with the new OMB
standards, clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398, and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender and/or
racial/ethnic groups, including subgroups if applicable, and b) investigators
must report annual accrual and progress in conducting analyses, as appropriate,
by sex/gender and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The
NIH maintains a policy that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them. This
policy applies to all initial (Type 1) applications submitted for receipt dates
after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants in
research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy
requires education on the protection of human subject participants for all
investigators submitting NIH proposals for research involving human subjects.
You will find this policy announcement in the NIH Guide for Grants and Contracts
Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
NIH GRANTS POLICY STATEMENT: The NIH Grants Policy Statement (NIHGPS) has been
revised and reissued. The provisions of the revised NIHGPS are effective for
all funded NIH grants and cooperative agreements with budget periods beginning
on or after March 1, 2001. The revised NIHGPS is available at:
http://grants.nih.gov/grants/policy/nihgps_2001.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on
hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research
using hESC lines that are registered in the NIH Human Embryonic Stem Cell
Registry will be eligible for Federal funding (see http://escr.nih.gov/). It is the
responsibility of the applicant to provide the official NIH identifier(s)for the
hESC line(s)to be used in the proposed research. Applications that do not
provide this information will be returned without review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to provide
public access to research data through the Freedom of Information Act (FOIA)
under some circumstances. Data that are (1) first produced in a project that is
supported in whole or in part with Federal funds and (2) cited publicly and
officially by a Federal agency in support of an action that has the force and
effect of law (i.e., a regulation) may be accessed through FOIA. It is
important for applicants to understand the basic scope of this amendment. NIH
has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm
Applicants may wish to place data collected under this PA in a public archive,
which can provide protections for the data and manage the distribution for an
indefinite period of time. If so, the application should include a description
of the archiving plan in the study design and include information about this in
the budget justification section of the application. In addition, applicants
should think about how to structure informed consent statements and other human
subjects procedures given the potential for wider use of data collected under
this award.
URLS IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore, we
caution reviewers that their anonymity may be compromised when they directly
access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving
the health promotion and disease prevention objectives of "Healthy People 2010,"
a PHS led national activity for setting priority areas. This Program
Announcement (PA), Silvio O. Conte Centers for Neuroscience Research, is related
to the priority area of mental health and mental disorders. Potential
applicants may obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople/.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal
Domestic Assistance No. 93.242. Awards are made under authorization of sections
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
administered under NIH grants policies described at
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR
52 and 45 CFR Parts 74 and 92. This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health Systems
Agency review.
The PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and discourage the use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care or early childhood
development services are provided to children. This is consistent with the PHS
mission to protect and advance the physical and mental health of the American
people.